Containment Technology Forum: Basics and Beyond (E06)
(2 CM Points Awarded for Industrial Hygienists;
Current as of 06 January 2010
Planned and Implemented by the ISPE Containment Community of Practice (COP)
Facing pharmaceutical containment challenges? Whether you are looking for basic information or a more detailed level of understanding on challenges and solutions for contained powder processing, this seminar provides up-to-date information on hazardous compound handling processes. On the first day, you can attend either a fundamental or intermediate track. Either prepares you to get the most out of a second day packed with case studies. Take away a better understanding of implementation of containment systems and strategies that are based on real world experience. Don’t miss opportunities to hear from, and network with, industry experts in the field of containment.
Effective process and equipment design as well as effective containment practices at the shop floor level will protect product from cross-contamination as well as providing operator protection. Seminar topics include containment basics, occupational exposure values, hierarchy of control, technology examples, contained sampling, and effective measurement/ testing methods. Day two will include case studies on various types of facilities, and will illustrate concepts in practice.
Hear the FDA’s perspective, and participate in a Q&A session on risk-based approaches for multi-product facilities and highlyhazardous compound containment topics.
This seminar is designed for process and plant engineers, quality and health and safety professionals, and production managers, among others, and will provide a basic understanding of powder containment concepts as well as fresh engineering solutions.
How You Will Benefit
At the conclusion of this session, participants will be able to:
- Recognize that different types of toxicology limits are set for worker, product, and environmental protection
- Recognize or describe the following containment concepts: Contain at the source; Containment challenge; Material migration; and Risk
- Identify containment technologies and their position in the containment hierarchy
- Recognize applications of hierarchy of containment solutions to real-world containment challenges
- Describe how other industry professionals solved containment challenges
- Understand new technologies available and how they impact containment and cross-contamination
Who Should Attend
Project/process/manufacturing engineers, environment and health/safety professionals, quality assurance, professionals from production/manufacturing operations, professionals from process development, owner/operator, consultants, and CMOs
- Jeff Campie, USA
- Richard Forsyth, Senior Consultant, Hyde Engineering + Consulting, USA
- Nigel Hamilton, Global Quality, Strategy and Process Excellence, Sanofi Aventis, United Kingdom
- Aisling Horan, Validation Scientist, Alkermes Plc, Ireland
- Edwin Melendez, Principle Consultant, Parexel, USA
- Mark O'Reilly, Director Engineering, Alkermes Pharma Ireland Ltd, Ireland
- Kimberly Ray, A. Director Project Mgmt, Oso Biopharmaceuticals Mfg LLC, USA
- Julian Wilkins, Vice President, PharmaConsult US Inc, USA
- Paul Wreglesworth, Independent Consultant, United Kingdom
Communities of Practice (COPs)
CPIP™ Knowledge Elements
This Webinar relates to the following CPIP™ Knowledge Elements:
Related Technical Documents, Articles, and Publications
- ISPE Baseline® Guide: Volume 1 – Active Pharmaceutical Ingredients
- ISPE Knowledge Briefs: Risk-Based Approaches to Cross-Contamination; Containment Hierarchy of Controls; and Dry Powder Sampling and the Containment of Hazardous Compounds
ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.
Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.